Systems and apparatuses for inserting an implant in intervertebral space

• US 9,233,011 B2
• Filed: 05/05/2014
• Issued: 01/12/2016
• Est. Priority Date: 09/15/2006
• Status: Active Grant

• Current Assignee: Xtant Medical Holdings, Inc. (OrbiMed Advisors LLC (China))
• Original Assignee: Pioneer Surgical Technology Incorporated (Surgalign Holdings, Inc.)
• Inventors: Trudeau, Jeffrey L., Janowski, Brian Patrick, Kilpela, Thomas, Jackson, Michael R., Bao, Qi-Bin
• Primary Examiner(s): Lawson, Matthew
• Application Number:
  US14/270,076
• Publication Number:
  US 20140236301A1
• Time in Patent Office: 617 Days
• Field of Search: 606 99-100
• US Class Current: 1/1
• CPC Class Codes: A61F 2/30965 Reinforcing the prosthesis by embedding particles or fibres during moulding or dipping
• CPC Class Codes: A61F 2/44 for the spine, e.g. vertebrae, spinal discs
• CPC Class Codes: A61F 2/442 Intervertebral or spinal discs, e.g. resilient non-disc-shaped intervertebral inflatable pockets A61F2/441; non-disc-shaped intervertebral fusion implants A61F2/4455
• CPC Class Codes: A61F 2/4425 made of articulated components
• CPC Class Codes: A61F 2/4611 of spinal prostheses
• CPC Class Codes: A61F 2/4684 Trial or dummy prostheses
• CPC Class Codes: A61F 2002/3008 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61F 2002/30112 Rounded shapes, e.g. with rounded corners
• CPC Class Codes: A61F 2002/30383 made by laterally inserting a protrusion, e.g. a rib into a complementarily-shaped groove
• CPC Class Codes: A61F 2002/30387 Dovetail connection
• CPC Class Codes: A61F 2002/30393 with additional means for limiting said rotation
• CPC Class Codes: A61F 2002/30485 plastically deformable
• CPC Class Codes: A61F 2002/30492 using a locking pin
• CPC Class Codes: A61F 2002/305 Snap connection
• CPC Class Codes: A61F 2002/30565 having spring elements
• CPC Class Codes: A61F 2002/30571 Leaf springs
• CPC Class Codes: A61F 2002/30578 having apertures, e.g. for receiving fixation screws
• CPC Class Codes: A61F 2002/30579 with mechanically expandable devices, e.g. fixation devices
• CPC Class Codes: A61F 2002/30594 slotted, e.g. radial or meridian slot ending in a polar aperture, non-polar slots, horizontal or arcuate slots
• CPC Class Codes: A61F 2002/30601 telescopic
• CPC Class Codes: A61F 2002/30662 : with rotation-limiting means
• CPC Class Codes: A61F 2002/30677 : Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• CPC Class Codes: A61F 2002/30823 : having the shape of a reverse dovetail
• CPC Class Codes: A61F 2002/30841 : Sharp anchoring protrusions for impaction into the bone, e.g. sharp pins, spikes
• CPC Class Codes: A61F 2002/30845 : with cutting edges
• CPC Class Codes: A61F 2002/30884 : Fins or wings, e.g. longitudinal wings for preventing rotation within the bone cavity
• CPC Class Codes: A61F 2002/30894 : inclined obliquely with respect to each other
• CPC Class Codes: A61F 2002/30899 : Protrusions pierced with apertures
• CPC Class Codes: A61F 2002/30904 : serrated profile, i.e. saw-toothed
• CPC Class Codes: A61F 2002/449 : comprising multiple spinal implants located in different intervertebral spaces or in different vertebrae
• CPC Class Codes: A61F 2002/4627 : with linear motion along or rotating motion about the instrument axis or the implantation direction, e.g. telescopic, along a guiding rod, screwing inside the instrument
• CPC Class Codes: A61F 2002/4628 : with linear motion along or rotating motion about an axis transverse to the instrument axis or to the implantation direction, e.g. clamping
• CPC Class Codes: A61F 2220/0025 : Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2230/0004 : Rounded shapes, e.g. with rounded corners
• CPC Class Codes: A61F 2250/0098 : radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61F 2310/00407 : Coating made of titanium or of Ti-based alloys
• CPC Class Codes: A61F 2310/00796 : Coating or prosthesis-covering structure made of a phosphorus-containing compound, e.g. hydroxy(l)apatite

Abstract

Systems and tools for inserting and securing an implant within the intervertebral space. An intervertebral disc implant with upper and lower bearing members with an articulation interface between the members for providing relative motion therebetween. The implant may be provided with various securing members for fixing the implant within the intervertebral space. A tool may be used to insert the implant, which includes a plurality of shiftable implant engaging members that are shiftable between non-engaging and engaging configurations to alternatively release or hold the implant.

Claims

1. A tool for inserting an intervertebral implant into an intervertebral space between adjacent vertebrae, comprising:

a tool body having a longitudinal tool axis;

a proximal handle portion of the tool body;

an actuator operably connected to the tool body;

first and second pairs of laterally adjacent shiftable prongs having elongate bodies and each pair having a prong with a superiorly extending distal projection and a laterally adjacent prong with an inferiorly extending distal projection, the superiorly and inferiorly extending distal projections extending in respective superior and inferior directions along a vertical axis orthogonal to the longitudinal axis, the first and second pairs of shiftable prongs disposed at a distal end of the tool body with each pair of shiftable prongs spaced laterally from the longitudinal axis and the other pair of shiftable prongs;

wherein one prong of each of the pairs is operably connected to the other laterally adjacent prong of the same pair of laterally adjacent prongs and to the actuator to shift the prongs between a non-engaging configuration, wherein the projections of the prongs are positioned for being out of engagement with the intervertebral implant, and an engaging configuration, wherein the superiorly extending distal projection of one prong of each pair shifts superiorly and the inferiorly extending distal projection of the other laterally adjacent prong of each pair shifts inferiorly for engaging with the intervertebral implant for manipulation and insertion thereof into the intervertebral space.

2. The tool according to claim 1, wherein each of the prongs comprise a distal implant engaging end portion having a distally extending portion and one of the superiorly and inferiorly extending distal projections that extend transversely from the distally extending portion for engaging with the intervertebral implant.

3. The tool according to claim 1, wherein the prong of each pair having the superiorly extending distal projection is located laterally outwardly relative to the longitudinal tool axis from the other adjacent prong of each pair having the inferiorly extending distal projection.

4. The tool according to claim 1, further comprising a plurality of tab members that project distally from the distal end of the tool body disposed laterally between the first and second pairs of shiftable prongs for engaging with and gripping the implant in combination with the shiftable prongs.

5. The tool according to claim 1, wherein the prongs in the non-engaging configuration have a compact configuration wherein the superiorly and inferiorly extending distal projections of each pair of laterally adjacent prongs are positioned side-by-side, and the prongs in the engaging configuration have an extended configuration wherein the superiorly and inferiorly extending distal projections of each pair of laterally adjacent prongs are vertically spaced from each other.

6. The tool according to claim 1, wherein the first and second pairs of shiftable prongs are laterally spaced apart from the longitudinal tool axis and disposed on opposite lateral sides of the tool body from one another.

7. The tool according to claim 1, wherein each of the prong bodies include a camming surface spaced proximally from the distal projection of the prong and the tool further comprises:

a transversely-oriented camming member operably connected to the actuator and operable to biasingly engage the camming surface of at least one of the prongs of each pair for shifting the prongs between the non-engaging and engaging configurations.

8. The tool according to claim 7, wherein each prong body extends along a longitudinal prong axis and the camming surface of each prong body is inclined relative to the longitudinal prong axis.

12. The tool according to claim 4, wherein the plurality of tab members comprise an upper tab member and first and second lower tab members, the first and second lower tab members being laterally spaced apart from one another.

9. An implant and tool combination for inserting an implant within an intervertebral space between adjacent vertebrae, comprising:

an intervertebral disc implant;

an upper bearing member of the intervertebral disc implant having a body, an outer facing bearing surface, and an inner facing surface;

a lower bearing member of the intervertebral disc implant having a body, an outer facing bearing surface, and an inner facing surface;

an articulation interface formed between portions of the inner facing surfaces of the upper and lower bearing members for allowing relative movement therebetween;

tool receiving recessed openings formed in the inner facing surface of each of the upper and lower bearing members;

a docking portion of the outer facing bearing surface of at least one of the upper and lower bearing members for receiving a complimentary tab member of a tool;

a tool for holding and inserting the intervertebral disc implant;

a tool body of the tool having proximal and distal ends and a longitudinal axis extending therebetween;

first and second pairs of laterally adjacent shiftable prongs disposed at the distal end of the tool body, the prongs having elongate bodies wherein one prong of each pair includes a superiorly extending distal projection and the other laterally adjacent prong of the same pair includes an inferiorly extending distal projection, the superiorly and inferiorly extending distal projections extending in respective superior and inferior directions along a vertical axis orthogonal to the longitudinal axis, the first and second pairs of prongs sized and configured to shift between a non-engaging configuration, wherein the prongs are positioned for being out of engagement with the intervertebral implant, and an engaging configuration, wherein the superiorly extending distal projection of one prong of each pair shifts superiorly and the inferiorly extending distal projection of the other laterally adjacent prong of each pair shifts inferiorly for being received in the tool receiving recessed openings for manipulating and inserting the bearing members into the intervertebral space; and

a tab member at the distal end of the tool body configured to be received by the docking portion causing the distal projections of the prongs to be positioned for being shifted inferiorly and superiorly to fit in the tool receiving recessed openings of the upper and lower bearing members.

10. The combination of claim 9, wherein the docking portion is recessed below the outer facing bearing surface of the at least one of the upper and lower bearing members, and the tool tab member for engaging with the docking portion is sized and configured such that tab member does not extend above the outer facing bearing surface surrounding the recessed docking portion with the tab member received by the docking portion.

11. The combination of claim 10, wherein the docking portion includes shelf-like recesses disposed on a proximal portion of the outer facing bearing surfaces.

13. The tool according to claim 9, wherein the first and second pairs of shiftable prongs are laterally spaced apart from the longitudinal axis and from one another.

14. The tool according to claim 9, wherein the upper and lower bearing members include docking portions, and the tab member of the tool comprises an upper implant engagement tab member for engaging with the docking portion of the upper bearing member, and the tool further comprises first and second lower implant engagement tab members for engaging with the docking portion of the lower bearing member, the first and second lower implant engagement tab members being laterally spaced apart from one another.

15. The tool according to claim 9, wherein each prong body includes a camming surface spaced proximally from the distal projection of the prong and the tool further comprises:

a transversely oriented camming member operable to biasingly engage the camming surface of at least one of the prongs of each pair for shifting the prongs between the non-engaging and engaging configurations.

16. The tool according to claim 15, wherein each prong body extends along a longitudinal prong axis and the camming surface of each prong body is inclined relative to the longitudinal prong axis.